Drug abuse has always been part of the American landscape since the founding of this country. And it all follows a familiar pattern – introduce a drug with great fanfare and promise, but with little warning about its habit-forming indications or possible side effects. Predictably, people become addicted, and this is followed by restriction and regulation creating criminal enterprise and a criminal class of addicts. Access to illicit drugs like opium, cocaine, marijuana and heroin, as well as prescribed and Physician administered legal drugs such as amphetamines, oxycodone and morphine, continue to make America the world’s leading marketplace per capita for drug use. The definition of insanity is doing the same thing over and over and expecting a different result. How many times do we have to live through this scenario before we learn how to avoid it?
History Of Drug Abuse In America
America experimented with opium in the early days of the Republic. According to “Inside the Story of America’s 19th-Century Opiate Addiction” by Erick Trickey for Smithsonian.com “Opium’s history in the United States is as old as the nation itself. During the American Revolution, the Continental and British armies used opium to treat sick and wounded soldiers. Benjamin Franklin took opium late in life to cope with severe pain from a bladder stone. A doctor gave laudanum, a tincture of opium mixed with alcohol, to Alexander Hamilton after his fatal duel with Aaron Burr.”
Fast forward to the Civil War and the use of opium spread faster than Typhoid Mary spread the plague. Trickey writes, “The Union Army alone issued nearly 10 million opium pills to its soldiers, plus 2.8 million ounces of opium powders and tinctures. An unknown number of soldiers returned home addicted, or with war wounds that opium relieved.” And just in case opioids needed more help in addicting the populace, the invention of hypodermic needle in the mid-1800s was quickly adopted by Physicians to administer to their Patients. Opium and morphine, like today’s newer class of opioids, were soon considered miracle drugs on and off the battlefield. They seemed like a cure-all for pain – everything from teething to menstrual cramps, as well as the ravages of war. And Doctors were freely recommending and dispensing them.
Hold Your Fire!
Let’s take a step back before we lay the blame at the feet of Doctors for the early 19th century addiction crisis that affected hundreds of thousands of Americans. Let’s put ourselves in the examining rooms of an era where Physicians had few tools in their medical bags. The Physician sees Patients in distress. Perhaps these same Patients have been there before and can find no relief. A fast-acting drug is readily available that will relieve that distress. The Food and Drug Administration didn’t exist until 1938, and its predecessor, the Bureau of Chemistry, was in the business of researching the adulteration and misbranding of food and drugs in America. The drug is freely available over the counter at any store. There is no internet. Journalists and those contributing to medical journals are the only ones raising concerns about overuse and abuse of these opioids with their voices being raised only after the snowball of opioid abuse, addiction and death had turned into an avalanche. Under these circumstances and if you had nothing else to offer, would you have recommended it to your Patients if you were that Doctor?
To the credit of Doctors at that time, once the dangers of these opioids were recognized, they immediately exercised caution and restricted the use of opioids. What followed was the spread of opium dens, street drugs and the criminalization of addiction. It is a tragic cycle that has been repeated time and time again for more than 100 years.
Oops! It Happened Again
The current opioid crisis began just as the opium and morphine crisis started more than 150 years ago. A miracle drug, fast-acting and highly effective, takes America by storm. Physicians start dispensing it to their Patients. This time around there was plenty of information available about it. In fact, there was too much information and misinformation about it. Purdue Pharma, a company owned by the Sackler family, introduced that miracle drug, oxycodone, a time-released opioid.
According to The New Yorker magazine Richard Sackler, a member of Purdue’s board, “helped imagineer a revolution in prescription analgesics. Like most revolutions, his began with a powerful idea: What if opioid painkillers were only addictive because they took effect instantly — which is to say, what if one could safely treat chronic pain with a patentable, extended-release opioid drug?”
It turns out that Sackler’s theory about extended-release opioids was more of a marketing strategy and less scientific theory. As The New Yorker reported, even the FDA was skeptical, but not skeptical enough. “Purdue failed to convince the Food and Drug Administration (FDA) that their signature opioid — OxyContin — came with little risk of abuse. Instead, the FDA merely signed off on the company’s claim that the drug’s extended-release formula was ‘believed to reduce’ (as opposed to ‘eliminate’) its appeal to addicts, who presumably favored a more immediate high.”
Nevertheless, Purdue backed the launch with a media blitz, $200 million marketing plan and a team of Doctors, nurses and pharmacists trained to speak at medical conferences to extol the virtues of this new painkiller. The push paid off. The American Journal of Public Health reported that “OxyContin prescriptions for non-cancer-related pain went from about 670,000 in 1997 to about 6.2 million by 2002 topping the $1.5 billion sales mark. In 2012 OxyContin represented about 30 percent of the overall painkiller market. Between 1991 and 2013, the number of annual opioid prescriptions in the U.S. increased from 76 million to 207 million, with corresponding increases in the number of cases of addiction, overdose and death.”
The very effective “ask your doctor” advertising prompting Patients in pain to lobby their Doctors for this new and magical pill combined with aggressive pharma sales people (carrying the imprimatur of FDA approval) offering a blizzard of studies and research that the magical pill is the best thing since sliced bread, as well as free samples and perks (financial and otherwise), to persuade Physicians to mainstream the drug was hard to resist.
Physicians Under More Pressure
Additional pressure on Physicians came from other Physicians funded by drug companies just before the turn of the 21st century to argue that the medical establishment was neglectful when it came to taking pain complaints from their Patients seriously and acting on it. According to Chancellor’s Professor of Medicine, Liberal Arts, and Philanthropy, Indiana University Richard Gunderman in his “Oxycontin: how Purdue Pharma helped spark the opioid epidemic,” a “Body and Soul, A doctor’s view” column for The Conversation, “They lobbied to have pain recognized as the ‘fifth vital sign,’ and urged physicians to be more liberal in their prescribing of opioids. Some of these physicians were associated with professional associations focused on treating pain.”
Gunderman also noted, “In 2000 the Joint Commission, the organization that accredits hospitals, began requiring health care organizations to prove that they were assessing and treating pain. This led to a more liberal approach for prescribing painkillers like OxyContin.”
As the crisis came to a head and gained national attention, Doctors who prescribed opioids became an easy target for blame. Were there Doctors who benefitted financially from prescribing opioids? Absolutely. Did they represent a majority or plurality of all Physicians? Absolutely not. Like their predecessors in the 19th century, most Physicians, faced with Patients in pain, criticized by the Joint Commission for not paying enough attention to Patients in pain and being assured by the FDA approval process and drug company run research and studies, used the best judgment they had at the time and dispensed the drug. On the prescribing end of things, insufficient scrutiny was given to powerful lobbying interests, as well as state and federal government bureaucrats who turned a blind eye to the gaming of the system taking place in their own backyards.
Florida’s Pill Mills
One state, known for tourism, became ground zero for opioid distribution. According to Terry Spencer for The Associated Press in the article “Florida ‘pill mills’ were ‘gas on the fire’ of opioid crisis,” the surge of opioid use coincided with Florida opening walk-in clinics that dispensed cheap and easy prescription painkillers, with, “parking lots filled with vehicles sporting license plates from Ohio, Kentucky, West Virginia and elsewhere. The customers were drawn by billboards on southbound interstates advertising quick and easy relief -- code for ‘We’re a pill mill and we’re ready to deal.’” Spencer quoted Andrew Kolodny, who researches addiction at Brandeis University, who explained, “You could think about the manufacturers as having lit the fire, and the distributors and pill mills were really pouring gas on the fire.”
And the fire raged for years. Spencer chronicles the time this way, “By 2010, 90 of the nation’s top 100 opioid prescribers were Florida doctors, and 85 percent of the nation’s oxycodone was prescribed in the state. That year alone, about 500 million pills were sold in Florida. The number of people who died in Florida with oxycodone or another prescription opioid in their system hit 4,282 in 2010, a four-fold increase from 2000, with 2,710 of the deaths deemed overdoses, according to a state medical examiners’ report.”
Eventually, the opioid crisis was exposed, and the pill mills in Florida and elsewhere, feeling the heat, folded their tents and went away. The carnage they left behind were desperate addicts being cut off from new prescriptions and turning to street heroin. With the horse out of barn and the damage done, the Department of Justice brought charges against Purdue for “misbranding the drug’s abuse potential.” Purdue and three of its executives pleaded guilty, and the government collected $600 million in fines from Purdue, the company that racked up billions in OxyContin sales. However, those who were considered the middlemen, which is defined as those assuming no risk and reaping all the rewards, did not suffer the same financial penalties as the companies they ran or owned. While class action suits can practically bankrupt a company, those middlemen can escape virtually unscathed unless the legal principle of “piercing the corporate veil” can be applied to these individuals. If this legal principle is applied, those injured by the crisis would be able to “claw back” the money that these individuals gained in this damaging pursuit of wealth.
Finally, in the category that it would be funny if it weren’t so tragic is this update about Purdue on WebMD from HealthDay in an article entitled, “OxyContin Maker Selling Opioid Addiction Drug, Too.” “Purdue Pharma, the maker of Oxycontin [sic] who some have blamed for the epidemic of opioid painkiller addictions, has patented a medicine aimed at curbing those disorders. The new anti-addiction drug is a fast-acting form of buprenorphine, which helps control drug cravings, CBS News reported. Previously prescribed in either tablet or fast-dissolving strips, the Purdue version comes in a ‘wafer’ that dissolves in only a few seconds. Richard Sackler, a member of Purdue’s board, is listed as one of the inventors on the patent, The Sackler family controls Purdue.”
Ironically, although there are prescribing restrictions on the dispensing of buprenorphine, OxyContin continues to be available to the public by prescription.
And it’s de ja vu all over again.
